BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2232204 · Received September 2, 2011

    Report

    Report Number
    1644487-2011-02051
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE MANUFACTURER'S CONSULTANT REPORTED THAT PRIOR TO THE PATIENT'S PROPHYLACTIC GENERATOR REPLACEMENT SURGERY THAT DAY, SHE PERFORMED SYSTEM DIAGNOSTICS WHICH REVEALED HIGH IMPEDANCE. THE NEUROLOGIST WAS NOT AWARE OF THE HIGH IMPEDANCE AND COULD NOT SAY EXACTLY WHEN THE LAST TIME DIAGNOSTICS WERE PERFORMED ON THE PATIENT. THE MOTHER REPORTED THAT THE PATIENT HADN'T BEEN HAVING ANY PROBLEMS. THE SURGERY WAS RESCHEDULED FOR (B)(6) 2011 DUE TO THE NEED FOR A FULL REVISION SURGERY. THE PATIENT'S GENERATOR WAS PROGRAMMED TO AN OUTPUT OF 0MA BECAUSE OF THE HIGH IMPEDANCE. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT FALLS A LOT AND SHE HAS TO SQUEEZE HIM VERY HARD ACROSS THE CHEST TO HOLD AND LIFT HIM SO THAT COULD BE THE REASON FOR A LEAD FRACTURE. THE PATIENT'S X-RAYS WERE RECEIVED BY THE MANUFACTURER AND NO GROSS LEAD DISCONTINUITIES OR SHARP ANGLES APPEARED TO BE PRESENT; HOWEVER SINCE THE PATIENT'S ELECTRODE AREA COULD NOT BE VISUALIZED IN THE X-RAYS AND A PORTION OF THE LEAD WAS HIDDEN BEHIND THE GENERATOR, COMMENTARY COULD NOT BE MADE ON THOSE PORTIONS. IT APPEARED THAT THE CONNECTOR PIN WAS FULLY INSERTED INTO THE CONNECTOR BLOCK OF THE GENERATOR. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED NEGATIVE YEARS UNTIL ERI=YES. THE FULL REVISION SURGERY TOOK PLACE ON (B)(6) 2011 AND THE EXPLANTED LEAD AND GENERATOR WERE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2011 THAT HAS NOT YET BEEN COMPLETED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 WHEN IT WAS REPORTED THAT THE PATIENT'S IMPEDANCE RESOLVED AFTER SURGERY ON (B)(6) 2011. THE LEAD WAS REPLACED DUE TO THE HIGH IMPEDANCE AND THE GENERATOR WAS REPLACED FOR PROPHYLACTIC REASONS. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED FOR PRODUCT ANALYSIS. A PORTION OF THE LEAD ASSEMBLY BODY INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED AND NO DISCONTINUITIES WERE IDENTIFIED. SINCE A PORTION OF THE LEAD ASSEMBLY BODY INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY COULD NOT BE MADE ON THAT PORTION OF THE LEAD. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND NO ERI FLAGS WERE OBSERVED DURING TESTING. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR